Devices and methods for shaping therapy in fluid enhanced ablation

ABSTRACT

Devices and methods for shaping an ablation treatment volume formed in fluid enhanced ablation therapy are provided. The devices and methods disclosed herein utilize the interaction of fluids to create ablation treatment volumes having a variety of shapes. In one embodiment, a method for forming an ablation treatment volume having a desired shape includes delivering therapeutic energy to tissue to form an ablation treatment volume and simultaneously delivering a first fluid and a second fluid to the tissue. The first and second fluids can convect the therapeutic energy in a desired direction such that the ablation treatment volume has a desired shape.

RELATED APPLICATIONS

This application claims priority to U.S. Provisional Application Ser.No. 61/474,574, filed on Apr. 12, 2011, and entitled “Improvement inAblation Catheters.” This application is also related to U.S.application Ser. No. ______ entitled “Devices and Methods for RemoteTemperature Monitoring in Fluid Enhanced Ablation Therapy,” U.S.application Ser. No. ______ “Methods and Devices for Heating Fluid inFluid Enhanced Ablation Therapy,” U.S. application Ser. No. ______“Methods and Devices for Controlling Ablation Therapy,” and U.S.application Ser. No. ______ “Devices and Methods for Use of DegassedFluids with Fluid Enhanced Ablation Devices,” respectively, and filedconcurrently with the present application. The disclosures of each ofthese applications are hereby incorporated by reference in theirentirety.

FIELD

The present invention relates generally to fluid enhanced ablation, suchas the SERF™ ablation technique (Saline Enhanced Radio Frequency™ablation). More particularly, this invention relates to devices andmethods for controlling the shape of a treatment zone created duringfluid enhanced ablation.

BACKGROUND

The use of thermal energy to destroy bodily tissue can be applied to avariety of therapeutic procedures, including the destruction of tumors.Thermal energy can be imparted to the tissue using various forms ofenergy, such as radio frequency electrical energy, microwave or lightwave electromagnetic energy, or ultrasonic vibrational energy. Radiofrequency (RF) ablation, for example, can be effected by placing one ormore electrodes against or into tissue to be treated and passing highfrequency electrical current into the tissue. The current can flowbetween closely spaced emitting electrodes or between an emittingelectrode and a larger, common electrode located remotely from thetissue to be heated.

One disadvantage with these techniques is that maximum heating oftenoccurs at or near the interface between the therapeutic tool and thetissue. In RF ablation, for example, the maximum heating can occur inthe tissue immediately adjacent to the emitting electrode. This canreduce the conductivity of the tissue, and in some cases, can causewater within the tissue to boil and become water vapor. As this processcontinues, the impedance of the tissue can increase and prevent currentfrom entering into the surrounding tissue. Thus, conventional RFinstruments are limited in the volume of tissue that can be treated.

Fluid enhanced ablation therapy, such as the SERF ablation technique(Saline Enhanced Radio Frequency™ ablation), can treat a greater volumeof tissue than conventional RF ablation. The SERF ablation technique isdescribed in U.S. Pat. No. 6,328,735, which is hereby incorporated byreference. Using the SERF ablation technique, saline is passed through aneedle and heated, and the heated fluid is delivered to the tissueimmediately surrounding the needle. The saline helps distribute the heatdeveloped adjacent to the needle and thereby allows a greater volume oftissue to be treated with a therapeutic dose of ablative energy. Thetherapy is usually completed once a target volume of tissue reaches adesired therapeutic temperature, or otherwise receives a therapeuticdose of energy.

Fluid enhanced ablation therapy generally creates a spherically-shapedtreatment zone in tissue surrounding an ablation device. In somesituations, however, it can be desirable to create a treatment zonehaving a non-spherical shape. For example, some lesions or tumorssuitable for treatment with fluid enhanced ablation are not spherical inshape. In addition, it can be desirable to protect certain structures,such as sensitive nerve cells, located very near to a lesion or othertarget volume of tissue.

In still other situations, it can be desirable to introducedirectionality into a treatment zone created using ablation therapy. Forexample, a common treatment for cardiac dysrhythmias, such as atrialfibrillation, involves a catheter-based procedure that selectivelyablates tissue in the atrial walls in order to create defined pathwaysfor the passage of the electrical signals that drive heartbeats. Currentmethods of ablation therapy, however, cannot create treatment zonessimilar to these directional pathways in the ventricle because theycannot heat through the ventricle wall, so this technique cannot beapplied to the treatment of ventricular tachycardia. Fluid enhancedablation is capable of heating through the ventricle wall, but theablation zones created are so large that it is not possible to createpathways for the electrical signals, as too much of the heart isablated.

Accordingly, there remains a need for improved devices and methods forshaping a treatment zone created during fluid enhanced ablation therapy.

SUMMARY

The present invention generally provides devices and methods forimproving ablation therapy by controlling the shape of the treatmentzone. In one aspect of the invention, a method for forming an ablationtreatment volume in tissue having a desired shape is provided thatincludes delivering therapeutic energy to tissue to form an ablationtreatment volume in the tissue, and simultaneously delivering a firstfluid and a second fluid to the tissue, the first and second fluidsconvecting the therapeutic energy in a desired direction such that theablation treatment volume has a desired shape.

In some embodiments, the method can further include deliveringadditional fluids to the tissue in combination with the first fluid andthe second fluid. For example, a third, fourth, fifth, etc. fluid can beintroduced in some embodiments. Each of these fluids can be introducedinto the tissue such that they interact to form an ablation treatmentvolume of a desired shape. Any number of fluids can be utilized.

In some embodiments, the first and second fluids can be delivered atdifferent temperatures. A number of different temperatures can beselected for the first and second fluids. In some embodiments, the firstfluid can be at about 50° C. In other embodiments, the second fluid canbe at about 37° C. However, any temperature can be selected for eitherthe first or the second fluid. Further, the method can be used in avariety of locations within a patient's body. In certain embodiments,for example, the tissue can be in the heart. In other embodiments, thetissue can be in the liver. In still other embodiments, the tissue canbe any of the prostate, uterus, kidney, lung, breast, or any other organor tissue within a patient's body.

In certain embodiments, the first and second fluids can be deliveredthrough one or more elongate bodies inserted into the tissue. Inaddition, the method can include a variety of other steps forfacilitating the shaping of the ablation treatment volume. For example,the method can further include adjusting any of a fluid flow rate and afluid temperature for any of the first fluid and the second fluid tofurther shape the ablation treatment volume. Similarly, the method canalso include adjusting a level of therapeutic energy delivered to thetissue to further shape the ablation treatment volume. In someembodiments, delivering therapeutic energy to tissue can includeactivating an ablation element configured to transmit electrical energyinto the tissue. Still further, in other embodiments, the method canfurther include repeating the steps of delivering therapeutic energy andsimultaneously delivering a first and a second fluid in a plurality oflocations to form a treatment volume having an elongate planar shape.

In some embodiments, the first fluid can be delivered from first andsecond opposed longitudinal portions of an inner lumen of an elongatebody, and the second fluid can be delivered from third and fourthopposed longitudinal portions of the inner lumen. In addition, the thirdand fourth portions can be radially offset from the first and secondportions.

In still other embodiments, delivering the first fluid can includeejecting the first fluid from at least one outlet port formed in aproximal portion of a sidewall of an elongate member, and delivering thesecond fluid can include ejecting the second fluid from at least oneoutlet port formed in a distal portion of a sidewall of an elongatemember adjacent to the proximal portion.

In still other embodiments, the method can include removing the firstand second fluids from the tissue so as to further shape the ablationtreatment volume. The first and second fluids can be selectively removedusing, for example, an elongate body configured to draw fluid fromtissue surrounding the elongate body.

In another aspect of the invention, a method for shaping therapeuticenergy delivered to tissue is provided that includes positioning a firstelongate body in a patient's body at a first location, where the firstelongate body has an inner lumen extending therethrough, at least oneoutlet port formed therein, at least one ablation element disposed alonga length thereof, and at least one heater element disposed within theinner lumen. The method further includes positioning a second elongatebody in a patient's body at a second location, where the second elongatebody has an inner lumen extending therethrough and at least one outletport formed therein. The method further includes simultaneouslydelivering a first fluid from the first elongate body and a second fluidfrom the second elongate body such that the first and second fluidsinteract to shape an ablation treatment volume.

The method can have a variety of modifications, all of which areconsidered within the scope of the invention. In some embodiments, forexample, the first fluid and the second fluid can be at differenttemperatures. In other embodiments, the method can further includedelivering therapeutic energy from the ablation element disposed alongthe first elongate body. In such an embodiment, the interaction of thefluid can direct the energy from the ablation element to shape thevolume of tissue that receives therapeutic energy.

In other embodiments, positioning the first elongate body at a firstlocation and positioning the second elongate body at a second locationcan include positioning in a patient's body an elongate member havingthe first and second elongate bodies disposed thereon. The elongatemember can be, for example, a catheter or other elongate shaft ormember, as discussed below. Further, in some embodiments, the secondelongate body can be positioned at a location adjacent to a structure tobe protected from therapeutic energy, such as a cluster of nerve cells.

In another aspect of the invention, an ablation device is provided thatincludes an elongate body having proximal and distal ends, an innerlumen extending through the elongate body, and at least two outlet portsformed in the elongate body configured to deliver fluid to tissuesurrounding the elongate body. The elongate body also includes at leastone ablation element disposed along a distal portion of the elongatebody, the ablation element being configured to heat tissue surroundingthe ablation element when the elongate body is inserted into tissue.Further, the at least two outlet ports are configured to deliver fluidat different temperatures.

The ablation device can have a variety of configurations and additionalfeatures. In some embodiments, the ablation device can further includeat least one heater element associated with one or more of the twooutlet ports, the at least one heater element being disposed within theinner lumen and configured to heat fluid flowing to the one or moreassociated outlet ports.

In other embodiments, the ablation device can further include at leastone dividing member disposed within the inner lumen and configured todivide the inner lumen into two or more portions not in fluidcommunication with each other. Further, each portion can be incommunication with one or more of the at least two outlet ports. Incertain embodiments, the at least one dividing member can divide theinner lumen into four portions extending longitudinally along the innerlumen so as to divide the inner lumen into quadrants having opposedpairs. A heater element can be disposed within each portion of the firstopposing pair of quadrants that is configured to heat fluid flowingtherethrough to a first temperature. Further, a heater element can bedisposed within each portion of the second opposing pair of quadrantsthat is configured to heat fluid flowing therethrough to a secondtemperature that is less than the first temperature. In still otherembodiments, the at least one dividing member can divide the inner lumeninto a proximal portion and a distal portion wherein each portion isassociated with a different ablation element. The at least one dividingmember can also include at least two dividing members that furtherdivide the inner lumen to create a third portion that is proximal ordistal to the distal portion. In certain embodiments, the device canalso include two or more temperature sensors, and each temperaturesensor can be disposed in a different portion of the inner lumen.

In another aspect of the invention, an ablation device is providedhaving an elongate member that has a distal end configured forintroduction into a patient's body. The device also includes at leasttwo elongate bodies disposed on the distal end of the elongate member.Each of the elongate bodies includes proximal and distal ends, an innerlumen extending therethrough, and at least one outlet port formed in theelongate body and configured to deliver fluid to tissue surrounding theelongate body. At least one of the elongate bodies includes at least oneablation element disposed along a distal portion of the elongate bodyand the ablation element is configured to heat tissue surrounding theablation element. Further, at least one of the elongate bodies includesa heater element disposed within the inner lumen of the elongate bodyand the heater element is configured to heat fluid flowing through theinner lumen.

In some embodiments, the at least two elongate bodies can include first,second, and third elongate bodies arranged around the distal end of theelongate member a distance away from a longitudinal axis of the elongatemember. For example, the first, second, and third elongate bodies can bearranged such that they are angularly offset from each other andpositioned at a particular radius from the longitudinal axis of theelongate member. In other embodiments, the first, second, and thirdelongate bodies can be positioned in a straight line on the distal endof the elongate member. In such an embodiment, one or more of theelongate bodies can include an ablation element thereon.

BRIEF DESCRIPTION OF THE DRAWINGS

The aspects and embodiments of the invention described above will bemore fully understood from the following detailed description taken inconjunction with the accompanying drawings, in which:

FIG. 1 is a diagram of one embodiment of a fluid enhanced ablationsystem;

FIG. 2 is a perspective view of one embodiment of a medical devicehaving an elongate body for use in fluid enhanced ablation;

FIG. 3 is a graphical representation of simulated heating profiles forvarious forms of ablation;

FIG. 4 is a side view of a distal portion of an elongate body showingthe expansion of a treatment zone over time;

FIG. 5 is a cross-sectional schematic of a treatment zone that can becreated by one embodiment of a fluid enhanced ablation system of thepresent invention;

FIG. 6 is a perspective view of one embodiment of an ablation devicehaving three elongate bodies extending longitudinally from a catheter;

FIG. 7A is a perspective view of one embodiment of an ablation devicethat includes an elongate body having an inner lumen divided intoportions extending longitudinally along the inner lumen;

FIG. 7B is a cross-sectional view of the device of FIG. 7A depictingfluid flow with arrows and showing resulting treatment zones;

FIG. 8A is a side view of one embodiment of an elongate body having aplurality of ablation elements disposed along the elongate body;

FIG. 8B is a perspective, semi-transparent view of the elongate body ofFIG. 8A showing the division of the elongate body into proximal anddistal portions that can each independently receive fluid at a giventemperature;

FIG. 9 is a cross-sectional view of one embodiment of a surgical siteshowing a tissue structure, a first elongate body delivering fluid at afirst temperature, and a second elongate body delivering fluid at asecond temperature to form a non-spherical treatment zone; and

FIG. 10 is a cross-sectional view of one embodiment of a surgical siteshowing a first elongate body delivering fluid and therapeutic energyinto a treatment zone and a second elongate body drawing fluid from thetreatment zone.

DETAILED DESCRIPTION

Certain exemplary embodiments will now be described to provide anoverall understanding of the principles of the devices and methodsdisclosed herein. One or more examples of these embodiments areillustrated in the accompanying drawings. Those skilled in the art willunderstand that the devices and methods specifically described hereinand illustrated in the accompanying drawings are non-limiting exemplaryembodiments and that the scope of the present invention is definedsolely by the claims. The features illustrated or described inconnection with one exemplary embodiment may be combined with thefeatures of other embodiments. Such modifications and variations areintended to be included within the scope of the present invention.

The terms “a” and “an” can be used interchangeably, and are equivalentto the phrase “one or more” as utilized in the present application. Theterms “comprising,” “having,” “including,” and “containing” are to beconstrued as open-ended terms (i.e., meaning “including, but not limitedto,”) unless otherwise noted. The terms “about” and “approximately” usedfor any numerical values or ranges indicate a suitable dimensionaltolerance that allows the composition, part, or collection of elementsto function for its intended purpose as described herein. These termsgenerally indicate a ±10% variation about a central value. Componentsdescribed herein as being coupled may be directly coupled, or they maybe indirectly coupled via one or more intermediate components. Therecitation of any ranges of values herein is merely intended to serve asa shorthand method of referring individually to each separate valuefalling within the range, unless otherwise indicated herein, and eachseparate value is incorporated into the specification as if it wereindividually recited. Further, to the extent that linear or circulardimensions are used in the description of the disclosed devices,systems, and methods, such dimensions are not intended to limit thetypes of shapes that can be used in conjunction with such devices,systems, and methods. A person skilled in the art will recognize that anequivalent to such linear and circular dimensions can easily bedetermined for any geometric shape.

All methods described herein can be performed in any suitable orderunless otherwise indicated herein or otherwise clearly contradicted bycontext. The use of any and all examples, or exemplary language (e.g.,“such as”), provided herein is intended merely to better illuminate theinvention and does not impose a limitation on the scope of the inventionunless otherwise claimed. No language in the specification should beconstrued as indicating any non-claimed element as essential to thepractice of the invention. Further, to the extent the term “saline” isused in conjunction with any embodiment herein, such embodiment is notlimited to use of “saline” as opposed to another fluid unless explicitlyindicated. Other fluids can typically be used in a similar manner.

Fluid Enhanced Ablation Systems

The present invention is generally directed to devices and methods forshaping a therapy or treatment zone or region created using fluidenhanced ablation. Fluid enhanced ablation, as mentioned above, isdefined by passing a fluid into tissue while delivering therapeuticenergy from an ablation element. The delivery of therapeutic energy intotissue can cause hyperthermia in the tissue, ultimately resulting innecrosis. This temperature-induced selective destruction of tissue canbe utilized to treat a variety of conditions including tumors, fibroids,cardiac dysrhythmias (e.g., ventricular tachycardia, etc.), and others.

Fluid enhanced ablation, such as the SERF™ ablation technique (SalineEnhanced Radio Frequency™ ablation) described in U.S. Pat. No. 6,328,735and incorporated by reference above, delivers fluid heated to atherapeutic temperature into tissue along with ablative energy.Delivering heated fluid enhances the ablation treatment because thefluid flow through the extracellular space of the treatment tissue canincrease the heat transfer through the tissue by more than a factor oftwenty. The flowing heated fluid therefore convects thermal energy fromthe ablation energy source further into the target tissue. In addition,the fact that the fluid is heated to a therapeutic temperature increasesthe amount of energy that can be imparted into the tissue. Finally, thefluid can also serve to constantly hydrate the tissue and prevent anycharring and associated impedance rise.

FIG. 1 illustrates a diagram of one exemplary fluid ablation system 100.The system includes an elongate body 102 configured for insertion into atarget volume of tissue. The elongate body can have a variety of shapesand sizes according to the geometry of the target tissue. Further, theparticular size of the elongate body can depend on a variety of factorsincluding the type and location of tissue to be treated, the size of thetissue volume to be treated, etc. By way of example only, in oneembodiment, the elongate body can be a thin-walled stainless steelneedle between about 16- and about 18-gauge (i.e., an outer diameter ofabout 1.27 millimeters to about 1.65 millimeters), and having a length L(e.g., as shown in FIG. 2) that is approximately 25 cm. The elongatebody 102 can include a pointed distal tip 104 configured to puncturetissue to facilitate introduction of the device into a target volume oftissue, however, in other embodiments the tip can be blunt and can havevarious other configurations. The elongate body 102 can be formed from aconductive material such that the elongate body can conduct electricalenergy along its length to one or more ablation elements located along adistal portion of the elongate body. Emitter electrode 105 is an exampleof an ablation element capable of delivering RF energy from the elongatebody.

In some embodiments, the emitter electrode 105 can be a portion of theelongate body 102. For example, the elongate body 102 can be coated inan insulating material along its entire length except for the portionrepresenting the emitter electrode 105. More particularly, in oneembodiment, the elongate body 102 can be coated in 1.5 mil of thefluoropolymer Xylan™ 8840. The electrode 105 can have a variety oflengths and shape configurations. In one embodiment, the electrode 105can be a 4 mm section of a tubular elongate body that is exposed tosurrounding tissue. Further, the electrode 105 can be located anywherealong the length of the elongate body 105 (and there can also be morethan one electrode disposed along the length of the elongate body). Inone embodiment, the electrode can be located adjacent to the distal tip104. In other embodiments, the elongate body can be formed from aninsulating material, and the electrode can be disposed around theelongate body or between portions of the elongate body.

In other embodiments, the electrode can be formed from a variety ofother materials suitable for conducting current. Any metal or metal saltmay be used. Aside from stainless steel, exemplary metals includeplatinum, gold, or silver, and exemplary metal salts includesilver/silver chloride. In one embodiment, the electrode can be formedfrom silver/silver chloride. It is known that metal electrodes assume avoltage potential different from that of surrounding tissue and/orliquid. Passing a current through this voltage difference can result inenergy dissipation at the electrode/tissue interface, which canexacerbate excessive heating of the tissue near the electrodes. Oneadvantage of using a metal salt such as silver/silver chloride is thatit has a high exchange current density. As a result, a large amount ofcurrent can be passed through such an electrode into tissue with only asmall voltage drop, thereby minimizing energy dissipation at thisinterface. Thus, an electrode formed from a metal salt such assilver/silver chloride can reduce excessive energy generation at thetissue interface and thereby produce a more desirable therapeutictemperature profile, even where there is no liquid flow about theelectrode.

The electrode 105 or other ablation element can include one or moreoutlet ports 108 that are configured to deliver fluid from an innerlumen 106 extending through the elongate body 102 into surroundingtissue (as shown by arrows 109). Alternatively, the electrode 105 can bepositioned near one or more outlet ports 108 formed in the elongate body102. In many embodiments, it can be desirable to position the electrodeadjacent to the one or more outlet ports to maximize the effect of theflowing fluid on the therapy. The outlet ports 108 can be formed in avariety of sizes, numbers, and pattern configurations. In addition, theoutlet ports 108 can be configured to direct fluid in a variety ofdirections with respect to the elongate body 102. These can include thenormal orientation (i.e., perpendicular to the elongate body surface)shown by arrows 109 in FIG. 1, as well as orientations directedproximally and distally along a longitudinal axis of the elongate body102, including various orientations that develop a circular or spiralflow of liquid around the elongate body. Still further, in someembodiments, the elongate body 102 can be formed with an open distal endthat serves as an outlet port. By way of further example, in oneembodiment, twenty-four equally-spaced outlet ports 108 having adiameter of about 0.4 mm can be created around the circumference of theelectrode 105 using Electrical Discharge Machining (EDM). One skilled inthe art will appreciate that additional manufacturing methods areavailable to create the outlet ports 108. In addition, in someembodiments, the outlet ports can be disposed along a portion of theelongate body adjacent to the electrode, rather than being disposed inthe electrode itself.

The inner lumen 106 that communicates with the outlet ports 108 can alsohouse a heating assembly 110 configured to heat fluid as it passesthrough the inner lumen 106 just prior to being introduced into tissue.Detailed discussion of various embodiments of the heating assembly 110suitable for use in devices and methods of the present invention can befound in related U.S. application Ser. No. ______, entitled “METHODS ANDDEVICES FOR HEATING FLUID IN FLUID ENHANCED ABLATION DEVICES,” filedconcurrently with the present application and incorporated by referencein its entirety above.

The portion of the elongate body located distal to the electrode 105 orother ablation element can be solid or filled such that the inner lumen106 terminates at the distal end of the electrode 105. In oneembodiment, the inner volume of the portion of the elongate body distalto the electrode can be filled with a plastic plug that can be epoxiedin place or held by an interference fit. In other embodiments, theportion of the elongate body distal to the electrode can be formed fromsolid metal and attached to the proximal portion of the elongate body bywelding, swaging, or any other technique known in the art.

Fluid can be supplied to the inner lumen 106 and heating assembly 110from a fluid reservoir 112. The fluid reservoir 112 can be connected tothe inner lumen 106 via a fluid conduit 114. The fluid conduit 114 canbe, for example, a length of flexible plastic tubing. The fluid conduit114 can also be a rigid tube, or a combination of rigid and flexibletubing.

Fluid can be urged from the fluid reservoir 112 into the inner lumen 106by a pump 116. The pump 116 can be a syringe-type pump that produces afixed volume flow with advancement of a plunger (not shown). An exampleof such a pump is a Model 74900 sold by Cole-Palmer Corporation ofChicago, Ill. Other types of pumps, such as a diaphragm pump, may alsobe employed.

The pump 116 can be controlled by a power supply and controller 118. Thepower supply and controller 118 can deliver electrical control signalsto the pump 116 to cause the pump to produce a desired flow rate offluid. The power supply and controller 118 can be connected to the pump116 via an electrical connection 120. The power supply and controller118 can also be electrically connected to the elongate body 102 viaconnection 122, and to a collector electrode 124 via connection 126. Inaddition, the power supply and controller 118 can be connected to theheating assembly 110 through a similar electrical connection.

The collector electrode 124 can have a variety of forms. For example,the collector electrode 124 can be a large electrode located outside apatient's body. In other embodiments, the collector electrode 124 can bea return electrode located elsewhere along the elongate body 102, or itcan be located on a second elongate body introduced into a patient'sbody near the treatment site.

In operation, the power supply and controller 118 can drive the deliveryof fluid into target tissue at a desired flow rate, the heating of thefluid to a desired therapeutic temperature, and the delivery oftherapeutic ablative energy via the one or more ablation elements, suchas electrode 105. To do so, the power supply and controller 118 canitself comprise a number of components for generating, regulating, anddelivering required electrical control and therapeutic energy signals.For example, the power supply and controller 118 can include one or morefrequency generators to create one or more RF signals of a givenamplitude and frequency. These signals can be amplified by one or moreRF power amplifiers into relatively high-voltage, high-amperage signals,e.g., 50 volts at 1 amp. These RF signals can be delivered to theablation element via one or more electrical connections 122 and theelongate body 102 such that RF energy is passed between the emitterelectrode 105 and the collector electrode 124 that can be locatedremotely on a patient's body. In embodiments in which the elongate bodyis formed from non-conductive material, the one or more electricalconnections 122 can extend through the inner lumen of the elongate bodyor along its outer surface to deliver current to the emitter electrode105. The passage of RF energy between the ablation element and thecollector electrode 124 can heat the tissue surrounding the elongatebody 102 due to the inherent electrical resistivity of the tissue. Thepower supply and controller 118 can also include a directional couplerto feed a portion of the one or more RF signals to, for example, a powermonitor to permit adjustment of the RF signal power to a desiredtreatment level.

The elongate body 102 illustrated in FIG. 1 can be configured forinsertion into a patient's body in a variety of manners. FIG. 2illustrates one embodiment of a medical device 200 having an elongatebody 202 disposed on a distal end thereof configured for laparoscopic ordirect insertion into a target area of tissue. In addition to theelongate body 202, the device 200 can include a handle 204 to allow anoperator to manipulate the device. The handle 204 can include one ormore electrical connections 206 that connect various components of theelongate body (e.g., the heating assembly and ablation element 205) to,for example, the power supply and controller 118 described above. Thehandle 204 can also include at least one fluid conduit 208 forconnecting a fluid source to the device 200.

While device 200 is one exemplary embodiment of a medical device thatcan be adapted for use in fluid enhanced ablation, a number of otherdevices can also be employed. For example, a very small elongate bodycan be required in treating cardiac dysrhythmias, such as ventriculartachycardia. In such a case, an appropriately sized elongate body canbe, for example, disposed at a distal end of a catheter configured forinsertion into the heart via the circulatory system. In one embodiment,a stainless steel needle body between about 20- and about 25-gauge(i.e., an outer diameter of about 0.5 millimeters to about 0.9millimeters) can be disposed at a distal end of a catheter. The cathetercan have a variety of sizes but, in some embodiments, it can have alength of about 120 cm and a diameter of about 8 French (“French” is aunit of measure used in the catheter industry to describe the size of acatheter and is equal to three times the diameter of the catheter inmillimeters).

Therapeutic Treatment Using Fluid Enhanced Ablation

Ablation generally involves the application of high or low temperaturesto cause the selective necrosis and/or removal of tissue. There is aknown time-temperature relationship in the thermal destruction of tissueaccomplished by ablation. A threshold temperature for causingirreversible thermal damage to tissue is generally accepted to be about41° Celsius (C). It is also known that the time required to achieve aparticular level of cell necrosis decreases as the treatment temperatureincreases further above 41° C. It is understood that the exacttime/temperature relationship varies by cell type, but that there is ageneral relationship across many cell types that can be used todetermine a desired thermal dose level. This relationship is commonlyreferred to as an equivalent time at 43° C. expressed as:

t _(eq.43° C.) =∫R ^((T(t)-43°)) dt  (1)

where T is the tissue temperature and R is a unit-less indicator oftherapeutic efficiency in a range between 0 and 5 (typically 2 fortemperatures greater than or equal to 43° C., zero for temperaturesbelow 41° C., and 4 for temperatures between 41 and 43° C.), asdescribed in Sapareto S. A. and W. C. Dewey, Int. J. Rad. Onc. Biol.Phys. 10(6):787-800 (1984). This equation and parameter set representsjust one example of the many known methods for computing a thermal dose,and any of methodology can be employed with the methods and devices ofthe present invention. Using equation (1) above, thermal doses in therange of t_(eq.43° C.)=20 minutes to 1 hour are generally accepted astherapeutic although there is some thought that the dose required tokill tissue is dependent on the type of tissue. Thus, therapeutictemperature may refer to any temperature in excess of 41° C., but thedelivered dose and, ultimately, the therapeutic effect are determined bythe temporal history of temperature (i.e., the amount of heating thetissue has previously endured), the type of tissue being heated, andequation (1). For example, Nath, S. and Haines, D. E., Prog. Card. Dis.37(4):185-205 (1995) (Nath et al.) suggest a temperature of 50° C. forone minute as therapeutic, which is an equivalent time at 43° C. of 128minutes with R=2. In addition, for maximum efficiency, the therapeutictemperature should be uniform throughout the tissue being treated sothat the thermal dose is uniformly delivered.

FIG. 3 illustrates the performance profiles of several ablationtechniques by showing a simulated temperature achieved at a givendistance from an ablation element, such as electrode 105. The firstprofile 302 illustrates the performance of RF ablation without the useof fluid enhancement. As shown in the figure, the temperature of thetissue falls very sharply with distance from the electrode. This meansthat within 10 millimeters of the ablation element the temperature ofthe tissue is still approximately body temperature (37° C.), far belowthe therapeutic temperature of 50° C. discussed above. Furthermore, veryclose to the ablation element the temperature is very high, meaning thatthe tissue will more quickly desiccate, or dry up, and char. Once thishappens, the impedance of the tissue rises dramatically, making itdifficult to pass energy to tissue farther away from the ablationelement.

A second tissue temperature profile 304 is associated with a secondprior art system similar to that described in U.S. Pat. No. 5,431,649.In this second system, an electrode is inserted into tissue and impartsa 400 kHz RF current flow of about 525 mA to heat the tissue. Bodytemperature (37° C.) saline solution is simultaneously injected into thetissue at a rate of 10 ml/min. The resulting tissue temperature profile304 is more uniform than profile 302, but the maximum temperatureachieved anywhere is approximately 50° C. Thus, the temperature profile304 exceeds the generally accepted tissue damaging temperature thresholdspecified for one minute of therapy in only a small portion of thetissue. As described above, such a small temperature increment requiressignificant treatment time to achieve any therapeutically meaningfulresults.

A third tissue temperature profile 306 is achieved using the teachingsof the present invention. In the illustrated embodiment, an electrodeformed from silver/silver chloride is inserted into tissue and imparts a480 kHz RF current flow of 525 mA to heat the tissue. Saline solutionheated to 50° C. is simultaneously injected into the tissue at a rate of10 ml/min. The resulting temperature profile 306 is both uniform andsignificantly above the 50° C. therapeutic threshold out to 15millimeters from the electrode. Moreover, because the temperature isuniform within this volume, the thermal dose delivered is also uniformthrough this volume.

The uniform temperature profile seen in FIG. 3 can be achieved by theintroduction of heated fluid into the target tissue during applicationof ablative energy. The fluid convects the heat deeper into the tissue,thereby reducing the charring and impedance change in tissue that occursnear the ablation element, as shown in profile 302. Further, because thefluid is heated to a therapeutic level, it does not act as a heat sinkthat draws down the temperature of the surrounding tissue, as seen inprofile 304. Therefore, the concurrent application of RF energy andperfusion of heated saline solution into the tissue eliminates thedesiccation and/or vaporization of tissue adjacent to the electrode,maintains the effective tissue impedance, and increases the thermaltransport within the tissue being heated with RF energy. The totalvolume of tissue that can be heated to therapeutic temperatures, e.g.,greater than 41° C., is thereby increased. For example, experimentaltesting has demonstrated that a volume of tissue having a diameter ofapproximately 8 centimeters (i.e., a spherical volume of approximately156 cm³) can be treated in 5 minutes using the fluid enhanced ablationtechniques described herein. By comparison, conventional RF can onlytreat volumes having a diameter of approximately 3 centimeters (i.e., aspherical volume of approximately 14 cm³) in the same 5-minute timespan.

In addition, fluid enhanced ablation devices according to the presentinvention have a greater number of parameters that can be varied toadjust the shape of the treatment profile according to the tissue beingtreated. For example, when using the SERF ablation technique, anoperator or control system can modify parameters such as salinetemperature (e.g., from about 40° C. to about 80° C.), saline flow rate(e.g., from about 0 ml/min to about 20 ml/min), RF signal power (e.g.,from about 0 W to about 100 W), and duration of treatment (e.g., fromabout 0 minutes to about 10 minutes) to adjust the temperature profile306. In addition, different electrode configurations can also be used tovary the treatment. For example, although the emitter electrode 105illustrated in FIG. 1 is configured as a continuous cylindrical bandadapted for a mono-polar current flow, the electrode can also be formedin other geometries, such as spherical or helical, that form acontinuous surface area, or the electrode may have a plurality ofdiscrete portions. The electrodes may also be configured for bipolaroperation, in which one electrode (or a portion of an electrode) acts asa cathode and another electrode (or portion thereof) acts as an anode.

A preferred fluid for use in the SERF ablation technique is sterilenormal saline solution (defined as a salt-containing solution). However,other liquids may be used, including Ringer's solution, or concentratedsaline solution. A fluid can be selected to provide the desiredtherapeutic and physical properties when applied to the target tissueand a sterile fluid is recommended to guard against infection of thetissue.

Fluid Shaping of Therapy Zone

As mentioned above, ablative energy generally expands from an ablationelement, such as emitter electrode 105, in a spherical pattern. This, inturn, creates ablation therapy treatment zones, volumes, or regions(i.e., regions that receive a therapeutic dose of ablative energy byreaching a therapeutic temperature for a period of time, as discussedabove) that have a roughly spherical shape. The diameter of thespherical treatment zone can increase as the treatment time islengthened.

One embodiment of this behavior is illustrated in FIG. 4. The figureshows one embodiment of an ablation device 400 that includes an elongatebody 402 having a distal tip 404 and an emitter electrode 405. Aplurality of outlet ports 408 can be positioned along an outer surfaceof the emitter electrode 405 and can be configured to deliver fluid intothe tissue surrounding the elongate body 402. As heated fluid isdelivered from the outlet ports 408 and ablative energy is deliveredinto the tissue via the emitter electrode 405, a treatment zone developsat a first time that is defined by the dotted lines labeled T₁. Whiledrawn as a two-dimensional circle, one skilled in the art willappreciate that the treatment zone represented is three-dimensional andis roughly spherical in shape. As the treatment time increases, so toodoes the diameter of the treatment zone, until it reaches the dottedlines labeled T₂ at a second time that is greater than the first time.Similarly, at a third time greater than the second time, the treatmentzone can reach the dotted lines labeled T₃.

In certain situations, however, it can be desirable to provide atherapeutic dose of ablative energy to a volume of tissue that is notspherically shaped. For example, in some embodiments ablation may beused to treat a fibroid, tumor, or other lesion that is notsymmetrically or spherically shaped. In other embodiments, the volume oftissue to be treated may be located very close to another tissuestructure to be spared from treatment, such as a cluster of nerve cellsor other healthy tissue. Still further, in some embodiments, it may bedesirable to create a treatment region having a definite directionality(e.g., a plane of ablated tissue having a length and a thickness). Anexemplary use for a directional treatment zone is the treatment ofcardiac dysrhythmias (e.g., ventricular tachycardia) with ablation. Insuch a procedure, ablation can be used to create directional paths toguide the propagation of the electrical signals that control heartbeats,thereby preventing errant signals that can produce a tachycardia. Thesepaths are commonly created as vertical planes in the walls of the heart.

The present invention provides devices and methods for producing thesetypes of directional and otherwise non-spherical treatment regionsduring fluid enhanced ablation therapy. In general, the devices andmethods of the present invention operate by using fluids of varyingtemperatures to shape the treatment region. In one embodiment, fluidheated to a therapeutic temperature can be introduced into tissue froman elongate body at one or more locations, and fluid at a lowertemperature can be introduced from the same or a different elongate bodyat one or more different locations. In certain regions surrounding theone or more elongate bodies, the higher temperature fluid can mix withthe lower temperature fluid, resulting in quenching (i.e., cooling ofthe heated fluid below a therapeutic temperature). This quenching canprevent the delivery of a therapeutic dose of ablative energy at aparticular location. The relative placement of the fluid sources, aswell as the selection of operating parameters such as flow rate andtemperature, can provide greater control and customization of thetreatment region created during fluid enhanced ablation therapy. Aperson skilled in the art will appreciate that the various methods anddevices disclosed herein can be used to create treatment regions havingany desired shape.

Multi-Body System

FIG. 5 illustrates one embodiment of a system of the present invention.The figure depicts a top cross-sectional view (i.e., the elongate bodiesdiscussed below extend through the page) of one embodiment of a fluidenhanced ablation system having multiple elongate bodies deliveringfluid at varying temperatures. In particular, a first elongate body 502can be positioned substantially in the center of a volume to be treated.The first elongate body 502 can be similar to the elongate body 102discussed above. A second elongate body 504 a and a third elongate body504 b can be positioned adjacent to the first elongate body 502 asshown. The second and third elongate bodies 504 a, 504 b can be similarto the elongate body 102 discussed above in some embodiments. In otherembodiments, however, the second and third elongate bodies can lack oneor more of the ablation element and the heating assembly of the elongatebody 102, as these bodies are not used to deliver therapeutically heatedfluid or ablative energy. In certain embodiments, a heating assembly maystill be included in the second and third elongate bodies 504 a, 504 bto allow them to heat fluid flowing therethrough to an elevatedtemperature, e.g., a temperature below the therapeutic threshold butabove body temperature (though any elevated temperature is possible).

In use, fluid from a first fluid source can be delivered into tissuesurrounding the first elongate body 502 by passing the fluid through theinner lumen, heating the fluid, and ejecting the fluid through at leastone outlet port formed in a sidewall of the elongate body 502, asdiscussed above. The heated fluid can be at a therapeutic temperature,for example, between about 45° C. and about 80° C. In one embodiment,the fluid can be heated to about 50° C. In addition, fluid of a second,lower temperature can be delivered from the same or different fluidsources into tissue surrounding the second and third elongate bodies 504a, 504 b. The lower temperature fluid can be any temperature less thanthe temperature of the fluid delivered through the elongate body 502. Inone embodiment, the lower temperature fluid can be between about 25° C.and about 41° C., though fluid of any temperature can be used so long asit quenches any thermal dose. The fluid flow from each of the first,second, and third elongate bodies 502, 504 a, 504 b is represented byarrows in FIG. 5. As mentioned above, the higher temperature fluidcoming out of the first elongate body 502 can mix with the lowertemperature fluids coming out of the second and third elongate bodies504 a, 504 b to prevent certain areas of tissue from reaching thetherapeutic temperature, thereby preventing tissue damage. This fluidinteraction and resulting selective quenching of heat in the tissue canproduce a treatment volume having an elliptical shape, as indicated bythe dotted lines labeled A₁ in FIG. 5. One skilled in the art willappreciate that while the treatment region A₁ in FIG. 5 is shown aselliptical, the treatment volume extends in three dimensions andresembles an elliptical disk or a sphere that has been compressed fromopposing sides by the fluid flows from the second and third elongatebodies 504 a, 504 b.

The configuration shown in FIG. 5 is one of a variety of possibleconfigurations for the fluid enhanced ablation system disclosed herein.For example, in certain embodiments, more than one elongate body may beconfigured to deliver therapeutically heated fluid, or heated fluid aswell as ablative energy. Similarly, more or less than the two elongatebodies 504 a, 504 b may be utilized to deliver fluid at a lowertemperature to areas adjacent to the one or more elongate bodies used toablate tissue. As a result, a number of different three-dimensionaltherapy zone shapes can be achieved using any number of elongate bodiessupplying fluid to the tissue. Still further, the one or more elongatebodies can be positioned at a variety of locations with respect to oneanother. Variations can include angular adjustments (e.g., placing thethird elongate body 504 b to the left of the first elongate body 502 inthe figure, rather than below), distance adjustments (e.g., moving thethird elongate body 504 b farther away from the first elongate body 502in the figure), and vertical adjustments (e.g., moving the secondelongate body 504 a in a direction normal to the plane of the figure).In addition, a variety of temperatures may be selected for the fluidsbeing delivered through any of the elongate bodies. In one embodiment,the fluid flowing through the first elongate body 502 can be heated to atherapeutic temperature. The fluids flowing through the second and thirdelongate bodies 504 a, 504 b can be heated to any temperature less thanthe therapeutic temperature. For example, the fluids can delivered atbody temperature with no active heating, or the fluids can be deliveredat a temperature below body temperature. Furthermore, the flow rates andtemperatures of the fluids injected from the first, second, and thirdelongate bodies can be adjusted to produce different variations of theshape shown in FIG. 5. In addition, the ablative energy delivered fromany ablation elements disposed on the elongate bodies can be varied, andany number of elongate bodies can be positioned in or around thetreatment zone to produce the desired therapy.

The elongate bodies 502, 504 a, 504 b depicted in FIG. 5 can beintroduced and positioned within a target volume of tissue in a varietyof manners as well. For example, three separate devices similar to themedical device 200 discussed above can be utilized. In some embodiments,however, an ablation device can be provided having a plurality ofelongate bodies affixed thereto where each elongate body can be coupledto the same or different fluid sources, as well as a heating assemblyand an ablation element, if required. FIG. 6 illustrates one embodimentof such a device 600 that can include an elongate shaft 610, a firstelongate body 602, a second elongate body 604 a, and a third elongatebody 604 b. The first elongate body 602 can be configured to deliverfluid heated to a therapeutic temperature to surrounding tissue alongwith ablative energy from, for example, an emitter electrode 605. Thesecond and third elongate bodies 604 a, 604 b can be configured todeliver fluid to the surrounding tissue at a lower temperature than thefirst elongate body 602. Additionally, each of the elongate bodies 602,604 a, 604 b can have one or more outlet ports 606 a, 606 b, 606 cconfigured to deliver fluid from the respective inner lumens of theelongate bodies 602, 604 a, 604 b into the surrounding tissue.

The elongate shaft 610 can have a variety of sizes and configurations.For example, in some embodiments the elongate shaft can be a catheterconfigured for entry into a patient's body via the circulatory system.In one exemplary embodiment, the catheter can be about 12 French.

Each of the first, second, and third elongate bodies 602, 604 a, 604 bcan be sized according to the overall diameter of the catheter used asthe elongate shaft 610. In one exemplary embodiment, each of theelongate bodies can be a 27 gauge stainless steel needle body (i.e.,having an outer diameter of about 0.4 mm). In another exemplaryembodiment, the elongate shaft 610 can be configured as a laparoscopicdevice similar to the medical device 200 discussed above.

The elongate bodies 602, 604 a, 604 b can be positioned in a variety ofconfigurations with respect to the elongate shaft 610. In the embodimentillustrated in FIG. 6, the elongate bodies 602, 604 a, 604 b can beevenly-spaced along an axis D that defines a diameter of the elongateshaft 610. More specifically, the first elongate body 502 can bepositioned at a central portion of the elongate shaft 610, and the firstelongate body 604 a and the second elongate body 604 b can be positionedalong the axis D at an outer portion of the diameter of the elongateshaft. The elongate bodies 602, 604 a, 604 b can extend in a directionthat is substantially parallel to a longitudinal axis L of the elongateshaft 610. In other embodiments, the elongate bodies 602, 604 a, 604 b,or at least the second and third elongate bodies 604 a, 604 b, can beconfigured to slide along the axis D to adjust the spacing between theelongate bodies 602, 604 a, 604 b. In still other embodiments, theelongate bodies 602, 604 a, 604 b can be angularly offset from eachother at a particular radius from the longitudinal axis L. For example,the elongate bodies 602, 604 a, 604 b can be positioned every 120° at adistance from the longitudinal axis L. In such an embodiment, ablationelements can be provided on each of the elongate bodies 602, 604 a, 604b and varying power levels, fluid flow rates, and fluid temperatures canbe utilized to produce desired therapy zones.

As mentioned above, the first elongate body 602 can include an ablationelement, such as the emitter electrode 605, configured to deliver RFenergy to heat tissue surrounding the elongate body 602. In certainembodiments, the second and third elongate bodies 604 a, 604 b mayinclude ablation elements as well (e.g., the ablation elements can beoperated at very low power or remain inactive during therapy) or, insome embodiments, may not include ablation elements at all. Furthermore,each of the elongate bodies 602, 604 a, 604 b can include a heatingassembly disposed within an inner lumen and configured to heat fluidflowing therethrough. The heating assemblies utilized can be similar tothose discussed above and in related U.S. application Ser. No. ______,entitled “METHODS AND DEVICES FOR HEATING FLUID IN FLUID ENHANCEDABLATION THERAPY,” filed concurrently with the present application andincorporated by reference in its entirety above. As mentioned above, thesecond and third elongate bodies 604 a, 604 b can, in some embodiments,not include a heating assembly, or an included heating assembly in eachof the second and third elongate bodies can remain inactive if heatingis not required or desired. Moreover, a person skilled in the art willappreciate that the elongate shaft can have any number of elongatebodies disposed thereon, and the elongate bodies can be oriented in avariety of angular directions with respect to the catheter.

Single-Body Devices

Effective shaping of the treatment zone created during fluid enhancedablation therapy can also be accomplished using devices having only asingle elongate body. For example, in one embodiment, an ablation devicecan include an elongate body with an inner lumen divided into two ormore portions not in fluid communication with each other where eachportion can be in communication with a common or separate fluid sourceand one or more different outlet ports positioned along the elongatebody. Accordingly, fluid can be delivered to different areas surroundingthe elongate body at a variety of temperatures. After exiting the one ormore outlet ports, the fluid can mix, resulting in selective quenchingof the heat building in certain areas of tissue surrounding the elongatebody. This selective quenching can prevent tissue damage, therebyshaping the volume of tissue that receives a therapeutic dose of energy.

FIG. 7A illustrates one embodiment of a single-body ablation device 700that includes an elongate body 702 having an inner lumen 706 that isdivided by a plurality of inner walls w₁, w₂, w₃, w₄ into a plurality ofportions in the form of quadrants 706 a, 706 b, 706 c, 706 d. Eachquadrant 706 a, 706 b, 706 c, 706 d therefore defines a separate innerlumen extending through the elongate body 702. A person skilled in theart will appreciate that inner lumens can be formed in the elongate bodyin other configurations, and that the elongate body can have any numberof inner lumens. The device 700 can also include a pointed (or otherwiseshaped) distal end 710, an ablation element (e.g., an emitter electrode)705, and a plurality of outlet ports 708.

The inner walls w₁, w₂, w₃, w₄ can extend along the entire length of theelongate body 702 such that the quadrants 706 a, 706 b, 706 c, 706 ddefined by the walls are not in fluid communication with each other. Theinterfaces between the inner walls w₁, w₂, w₃, w₄ and the inner wall ofthe elongate body 702 can include features, such as a sealant oradhesive, that prevent fluid from leaking between the quadrants 706 a,706 b, 706 c, 706 d. Furthermore, the inner walls w₁, w₂, w₃, w₄ can beformed from or coated in a thermally and possibly electricallyinsulating material to prevent heated fluid in one quadrant from warmingfluid in an adjacent quadrant. For example, the inner walls w₁, w₂, w₃,w₄ can be formed from or coated in the same fluoropolymer discussedabove with respect to the elongate body 102. In some embodiments,thermal insulation may not be necessary. For example, a fast fluid flowrate (e.g., 10 ml/min or more) can reduce the amount of time fluidspends traveling through the inner lumen 706, thereby reducing theamount of heat transfer that can occur between adjacent quadrants.

Each of the quadrants 706 a, 706 b, 706 c, 706 d can be in fluidcommunication with one or more of the outlet ports 708. For example, inthe embodiment illustrated in FIG. 7A, quadrant 706 a of inner lumen 706can be in fluid communication with one or more of the outlet ports 708that direct fluid in a positive y direction. Conversely, quadrant 706 bcan be in fluid communication with one or more of the outlet ports 708that direct fluid in a negative y direction. Similarly, quadrants 706 cand 706 d can be in fluid communication with one or more of the outletports 708 that direct fluid in a negative x direction and positive xdirection, respectively. A person skilled in the art will appreciatethat the quadrants 706 a, 706 b, 706 c, 706 d can each be in fluidcommunication with different outlet ports than those shown in FIG. 7A,and that any number of outlet ports can be positioned at variouslocations along the elongate body 702.

FIG. 7B illustrates the device of FIG. 7A in cross-section. As shown,fluid ejected from quadrants 706 c and 706 d of the inner lumen 706 canbe heated to a therapeutic temperature by separate heating assembliesdisposed within each quadrant (not shown). Fluid ejected from quadrants706 a and 706 b, on the other hand, can be at a second temperature thatis less than the therapeutic temperature of the fluid delivered fromquadrants 706 c and 706 d. As described above, the second temperaturecan be less than body temperature, equal to body temperature, or greaterthan body temperature but less than the selected therapeutictemperature. Further, this second temperature can be achieved bydelivering fluid at the second temperature or by utilizing separateheating assemblies (not shown) in the quadrants 706 c, 706 d to heat thefluid flowing therethrough to the second temperature. As the fluid fromeach quadrant enters tissue surrounding the elongate body 702, it canmix and form the thermal boundaries shown by the dotted lines. Theseboundaries can define treatment zones A₂ and A₃ in which a therapeutictemperature is reached for a period of time sufficient to deliver atherapeutic dose of ablative energy. Tissue outside zones A₂ and A₃ canbe prevented from receiving the therapeutic dose of ablative energy bythe cooler fluid being ejected from quadrants 706 a and 706 b. A personskilled in the art will appreciate that each of the quadrants 706 a, 706b, 706 c, 706 d can eject fluid at different temperatures and flow ratesto form a variety of differently shaped therapy zones.

FIGS. 8A and 8B illustrate another embodiment of a single-body ablationdevice 800 configured to deliver fluid at a variety of temperatures intoa treatment volume. In contrast to the portions extending longitudinallythrough the inner lumen 706 in the device 700 depicted in FIGS. 7A and7B, the device 800 can be divided into distal and proximal portions 802a, 802 b. As shown in FIG. 8A, the ablation device 800 can include anelongate body 802 that is divided into a distal portion 802 a and aproximal portion 802 b by a baffling element 803. The baffling element803 can be an inner wall that separates the inner lumen of the distalportion 802 a of the elongate body from the inner lumen of the proximalportion 802 b of the elongate body.

Each portion 802 a, 802 b can include an ablation element, such as anemitter electrode 805 a, 805 b, as well as one or more outlet ports 808a, 808 b formed along the elongate body 802 and/or emitter electrode 805a, 805 b that are in fluid communication with the inner lumen of eachportion. The portions 802 a, 802 b can further include one or moretemperature sensors 804 a, 804 b disposed along the elongate body andconfigured to detect the temperature of tissue surrounding the elongatebody 802. The temperature sensors can be implemented in a variety ofmanners and, in some embodiments, the sensors can be fine-wirechromel-constantan thermocouples embedded in a hole formed in thesidewall of the elongate body 802. The temperature sensors 804 a, 804 bcan be positioned at any location along the elongate body 802 but, insome embodiments, can be positioned symmetrically with respect to theablation elements 805 a, 805 b. Such an arrangement can allow for a moreaccurate measurement of the uniformity of expansion of the treatmentzone. More information regarding the temperature sensors can be found inrelated U.S. patent application Ser. No. ______, entitled “DEVICES ANDMETHODS FOR REMOTE TEMPERATURE MONITORING IN FLUID ENHANCED ABLATIONDEVICES,” filed concurrently with the present application andincorporated by reference above.

The division of the elongate body 802 into portions 802 a, 802 b canallow adjustment of the treatment zone in the event non-uniform heatingis detected by the temperature sensors 804 a, 804 b. For example, theillustrated device can be particularly useful in the situation wherefluid is delivered from both portions 802 a, 802 b at an equaltemperature along with ablative energy from both electrodes 805 a, 805b, but the temperature registered by temperature sensor 804 a is greaterthan the temperature registered by sensor 804 b. To adjust the therapyzone and provide more uniform heating, the delivery of ablative energyfrom electrode 805 a can be reduced or stopped. In addition, thetemperature of fluid being ejected from the one or more outlet ports 808a of distal portion 802 a can be reduced. Furthermore, the fluid flowrate can be decreased if necessary. Each of these actions can reduce theheating taking place in the tissue surrounding distal portion 802 a andhelp drive heated fluid being ejected from the outlet ports in proximalportion 802 b toward the temperature sensor 804 b and the tissuesurrounding the elongate body 802 in that area. One skilled in the artwill appreciate that the opposite steps (e.g., an increase in ablativeenergy, increase in saline temperature, etc.) can be applied to theportion 802 a to increase the thermal dose delivered in that area.Furthermore, any of the steps recited above can be applied in reverse toprovide more heating in the vicinity of the temperature sensor 804 ashould the observed conditions be reversed. Still further, the stepslisted above can be performed in any order and may be performedindividually or in concert depending on the amount of therapy shapingthat is desired or required.

FIG. 8B illustrates a semi-transparent view of the device of FIG. 8A andshows the internal construction of one embodiment of an elongate bodyhaving proximal and distal portions separated by one or more bafflingmembers 803. As shown, the inner lumen of distal portion 802 a can beseparated from proximal portion 802 b by the baffling member 803. Thebaffling member 803 can be constructed similarly to the walls w₁, w₂,w₃, w₄ discussed above. For example, the baffling member can be anintegrated portion of the elongate body 802, or can be a separatecomponent secured in the inner lumen 806 of the elongate body 802 by anadhesive or other retaining component or material. The baffle 803 can beformed, for example, from a plastic or other suitable material.

The baffling element 803 can further include one or more lumens formedtherein that are each configured to receive a cannula, such as cannula810 a. The cannula 810 a can be formed from metal, plastic, or plastichaving a metal lining, and can include an inner lumen that provides afluid passageway to the proximal end of the device 800 through anyintervening baffles (e.g., the baffle 803) and portions (e.g., theproximal portion 802 b). The inner lumen of the cannula 810 a is not influid communication with the inner lumen of any other portion (e.g.,proximal portion 802 b). This allows, for example, fluid to be deliveredinto distal portion 802 a from a source that is separate from the sourceused to deliver fluid to proximal portion 802 b. Alternatively, fluidcan be delivered into both portions 802 a, 802 b from a common source.The inner lumen 806 can also include additional cannulas configured todeliver fluid to other portions of the device 800. For example, theinner lumen 806 can include a cannula 810 b configured to deliver fluidfrom a proximal end of the device 800 into the proximal portion 802 b ofthe distal end of the device 800.

One skilled in the art will appreciate that the inner lumen 806 caninclude as many cannulas as there are portions in the device. Further,the device 800 can have any number of portions depending on the desiredshape of the treatment zone. For example, the device 800 can include twoportions as illustrated in FIG. 8, or can have three or more portions.In an embodiment having three portions, for instance, acentrally-located ablation element can be bordered on each side by oneor more outlets configured to deliver lower temperature fluid into thetissue surrounding the elongate body 802. In such an embodiment, thebordering outlets can compress the treatment zone along the direction ofa longitudinal axis of the elongate body 802.

In addition, the cannulas can each be rigidly held in position by aspacer element (e.g., an element similar to the baffle 803 but alsoincluding one or more lumens to allow the passage of fluid around thebaffle) or can be allowed to float in the inner lumen 806. In otherembodiments, the cannulas can include features formed on an externalsurface thereof to prevent contact with other cannulas or the innerwalls of the inner lumen 806. Exemplary features include fins or ribsformed on the outer surface of the cannulas.

Each cannula 810 a, 810 b can be connected at a proximal end to anindependent or common fluid source. Each cannula 810 a, 810 b can alsoinclude an independent heating assembly disposed within the inner lumenof the cannula near its distal end. An exemplary heating assembly caninclude, for example, a single wire 814 a, 814 b running through theinner lumen of the cannula 810 a, 810 b that is configured to pass RFenergy through fluid within the inner lumen of the cannula into theinner wall of the cannula. The wire 814 a, 814 b can include one or morespacers disposed thereon to prevent the wire from directly contactingthe conductive portion of the cannula 810 a, 810 b. A more detaileddescription of such a heating assembly can be found in U.S. applicationSer. No. ______, entitled “METHODS AND DEVICES FOR HEATING FLUID INFLUID ENHANCED ABLATION THERAPY,” filed concurrently with the presentapplication and incorporated by reference above.

The exemplary heating assembly described above requires that eachcannula 810 a, 810 b be at least partially formed from an electricallyconductive material (to receive RF energy from the wire 814 a, 814 b).In such an embodiment, the cannulas 810 a, 810 b can be coated in aninsulating material so as to prevent any electrical shorts due tocontact with each other or the inner walls of the inner lumen 806 of thedevice 800. In addition, a thermally insulating material can also beused to coat the cannulas 810 a, 810 b to prevent the temperature offluid in any one portion from influencing the temperature of fluid inother portions. However, in some embodiments, the fluid flow rate can behigh enough that fluid does not spend enough time in any one portion toinfluence, or be influenced by, the temperature of fluid in thatportion. In these embodiments, thermal insulation of the cannulas 810 a,810 b is not necessary.

The cannulas 810 a, 810 b can also include a temperature sensorconfigured to provide feedback regarding the temperature of fluid beingdelivered to a portion of the device 800. For example, the cannula 810 acan include a dual-wire thermocouple 812 a configured to extend beyondthe distal end of the cannula 810 a such that the thermocouple canmeasure the temperature of fluid within the distal portion 802 a afterit exits the cannula and mixes within the inner lumen 806 before exitinginto the surrounding tissue through the outlet ports 808 a. The twothermocouple wires 820, 822 can extend through the inner lumen of thecannula 810 a back to the proximal end of the device 810 a. The wirescan be connected to signal processing electronics as known in the art todetermine the temperature of the fluid in the distal portion 802 a. Asshown in the figure, the second cannula 810 b can also include atemperature sensor 812 b, such as a dual-wire thermocouple formed fromtwo wires 816, 818. The sensor 812 b can similarly be configured toextend beyond the distal end of the cannula 810 b into the proximalportion 802 b such that the temperature measured by the sensor 812 brepresents the temperature of mixed fluid that is about to be deliveredinto surrounding tissue via outlet ports 808 b. One skilled in the artwill appreciate that a variety of temperature sensors can be employed inthe devices of the present invention, including, for example,chromel-constantan fine-wire thermocouples.

Methods of Use

The teachings of the present invention can be utilized to produce atreatment zone having any desired shape. In general, this can beaccomplished by introducing fluid from two or more locations along withtherapeutic energy (e.g., from an ablation element or from heating thefluid alone). For example, in some embodiments, a method can includedelivering ablative energy and heated fluid at one or more locationswhile simultaneously delivering lower temperature fluid at one or moredifferent locations to produce the desired treatment zone shape. By wayof further example, in certain situations, it can be desirable toprovide a generally spherical treatment volume but to exclude aparticular subset of the volume from receiving a therapeutic dose ofablative energy. When utilizing fluid enhanced ablation in the area ofthe prostate, for example, it can be desirable to protect the nearbybundle of nerves that control incontinence and erectile function. Usingthe teachings of the present invention, this can be accomplished byintroducing an elongate body into tissue adjacent to the structure to beprotected and delivering a fluid below a selected therapeutictemperature during therapy, while simultaneously delivering energy totissue to be treated.

FIG. 9 illustrates a top cross-sectional view (similar to FIG. 5 above)of one embodiment of a non-spherical treatment zone. As shown in thefigure, a first elongate body 902 is positioned substantially in thecenter of a treatment volume. The treatment volume, however, is locatedadjacent to a structure 901 (e.g., nerve bundle, healthy tissue, etc.)to be spared from the ablation therapy. To accomplish this, a secondelongate body 904 can be positioned adjacent to the structure 901 andbetween the first elongate body 902 and the structure 901. During thefluid enhanced ablation therapy, in which the first elongate bodydelivers fluid heated to a therapeutic temperature along with RF energyinto the surrounding tissue, the second elongate body 904 can deliverfluid into the surrounding tissue at a temperature below the therapeutictemperature. As discussed above, the fluids can mix in the surroundingtissue and reduce the temperature in the tissue surrounding thestructure 901 below the therapeutic level. The resulting therapytreatment region is shown by the dotted lines labeled A₄. One skilled inthe art will appreciate that this technique, as well as variationsinvolving multiple ablative and non-ablative elongate bodies, can beused to protect a variety of tissue structures throughout the body.

In other embodiments, shaping of a treatment zone can be accomplishedusing a single elongate body configured to deliver fluid at multipletemperatures simultaneously. Such a device is described above and oneexemplary treatment zone is illustrated in FIGS. 7A and 7B. Anotherembodiment of such a device is illustrated in FIGS. 8A and 8B. In use,any of these devices can be introduced laparoscopically orendoscopically into a patient's body and positioned adjacent to tissueto be treated. Fluid can then be delivered into the tissue to be treatedthrough one or more inner lumens of the device. The fluid flowingthrough each inner lumen can be independently heated to a therapeutictemperature, or any temperature below the therapeutic temperature.Fluids at different temperatures can be delivered from differentportions—along the length of the device or around its circumference—ofthe device to produce treatment zones of different shapes.

In still other embodiments, it can be desirable to shape a therapytreatment zone by introducing an elongate body configured to removefluid from the surrounding tissue rather than deliver fluid into thetissue. Utilizing an elongate body configured to draw fluid fromsurrounding tissue can aid in developing a desired fluid flow patternwithin a volume of tissue undergoing treatment. In some embodiments,withdrawing fluid may also be necessary when the treatment volume isunable to absorb and dissipate the quantities of fluid introduced duringablation therapy.

FIG. 10 illustrates one embodiment of a method of delivering fluidenhanced ablation using one elongate body to deliver heated fluid andone elongate body to remove fluid from a treatment volume. As shown inthe figure, a first elongate body 1002 can be inserted into a treatmentvolume 1004. Unlike the embodiments described above, however, theelongate body 1002 can be positioned such that the ablation element 1006is located to one side of the treatment volume 1004, rather than beinglocated substantially in the center of the treatment volume. A secondelongate body 1008 can then be inserted into the treatment volume at aposition substantially opposed to the first elongate body 1002. Thesecond elongate body 1008 need not have an ablation element or, if itdoes, the ablation element can be deactivated. Further, the secondelongate body 1008 can be configured to withdraw fluid from thesurrounding tissue by, for example, connecting the inner lumen (that isin fluid communication with the surrounding tissue via one or moreoutlet ports 1010) of the second elongate body 1008 to a vacuum source.

After both the first and second elongate bodies 1002, 1008 arepositioned within the treatment volume 1004, the first elongate body canbegin delivering therapeutic energy from the ablation element 1006 aswell as fluid heated to a therapeutic level from the one or more outletports 1012 formed in a sidewall of the elongate body 1002 or ablationelement 1006. The second elongate body 1008 can also be activated tobegin withdrawing fluid from the tissue in the treatment volume 1004.The simultaneous introduction and removal of fluid from the treatmentvolume can result in the development of a directional flow patternbetween the first elongate body 1002 and the second elongate body 1008,as shown by the arrows in the figure.

One skilled in the art will appreciate that the technique of withdrawingfluid from a treatment area can be combined with any of the othertechniques described herein to create a variety of complex therapytreatment zones having a number of shapes. Further, multiple elongatebodies configured to deliver ablative energy or withdraw fluidintroduced into the treatment zone can be utilized concurrently. Stillfurther, the placement of the first and second elongate bodies need notnecessarily be opposed from one another, depending on the shape of thedesired therapy region and the ability to access portions thereof. Infact, in some embodiments, the introduction and removal of fluid can beaccomplished using a single elongate body, such as the device 800 shownin FIG. 8. In such an embodiment, one of the portions of the device canbe configured to introduce fluid into a treatment volume, while anotherof the portions of the device can be configured to remove fluid from thevolume.

The method illustrated in FIG. 10 can be particularly useful, forexample, when treating encapsulated lesions, such as uterine fibroids.Encapsulated lesions have an outer coating that does not permit thepassage of fluid, such as the fluid introduced during fluid enhancedablation. As a result, if fluid is not withdrawn during therapy, thelesion can be undesirably stressed by the introduction of a significantvolume of incompressible fluid. In addition, by positioning the firstand second elongate bodies 1002, 1008 as shown in the figure, a strongdirectionality (as shown by the arrows) can be imposed on thepropagation of the heat being delivered by the first elongate body 1002.Accordingly, therapy completion can be determined by measuring thetemperature of the tissue surrounding the second elongate body 1008using, for example, the same types of temperature sensors discussedabove.

The various embodiments of the devices and systems disclosed herein canbe utilized in a variety of surgical procedures to treat a number ofmedical conditions. For example, medical devices as disclosed herein canbe configured for insertion into a target volume of tissue directlyduring an open surgical procedure. Alternatively, the medical devicescan be configured to be passed through one or more layers of tissueduring a laparoscopic or other minimally invasive procedure.Furthermore, the devices can be configured for introduction into apatient via an access port or other opening formed through one or morelayers of tissue, or via a natural orifice (i.e., endoscopically).Following delivery to a treatment site, a portion of a surgical device,e.g., a distal portion of the elongate body 102, can be inserted into atarget treatment volume such that an ablation element is disposed withinthe treatment volume. In some embodiments, the ablation element can bepositioned near the center of the treatment volume.

Once the devices are positioned within the treatment volume, ablativeenergy and fluid heated to a therapeutic temperature can be deliveredthrough one or more of the devices into the treatment volume. Inaddition, one or more other devices can deliver fluid at a lowertemperature or withdraw fluid from the treatment volume. After a periodof time, or depending on one or more feedback indications (e.g., areading from a temperature sensor disposed within the treatment volume),the delivery of ablative energy and fluid can be stopped. The devicescan then be removed and/or repositioned if additional therapy isrequired.

In addition, a large treatment zone having a first shape can be createdby connecting several smaller treatment zones having a second shape. Forexample, a large linear treatment zone can be created by applyingtherapy that creates a slice-like shape (e.g., as shown in FIG. 5) andrepositioning the device such that the ends of subsequent treatmentzones overlap. A variety of other shapes can also be created using asimilar method of connecting smaller treatment zones of a given shapeand size.

Sterilization and Reuse

The devices disclosed herein can be designed to be disposed after asingle use, or they can be designed for multiple uses. In either case,however, the device can be reconditioned for reuse after at least oneuse. Reconditioning can include any combination of the steps ofdisassembly of the device, followed by cleaning or replacement ofparticular pieces, and subsequent reassembly. In particular, the devicecan be disassembled, and any number of the particular pieces or parts ofthe device can be selectively replaced or removed in any combination.Upon cleaning and/or replacement of particular parts, the device can bereassembled for subsequent use either at a reconditioning facility or bya surgical team immediately prior to a surgical procedure. Those skilledin the art will appreciate that reconditioning of a device can utilize avariety of techniques for disassembly, cleaning/replacement, andreassembly. Use of such techniques, and the resulting reconditioneddevice, are all within the scope of the present invention.

For example, the surgical devices disclosed herein may be disassembledpartially or completely. In particular, the elongate body 202 of themedical device 200 shown in FIG. 2 may be removed from the handle 204,or the entire handle and elongate body assembly may be decoupled fromthe electrical and fluid connections 206, 208. In yet anotherembodiment, the handle, elongate body, and connections may be removablycoupled to a housing that contains, for example, the fluid reservoir,pump, and power supply and controller shown in FIG. 1.

Preferably, the devices described herein will be processed beforesurgery. First, a new or used instrument can be obtained and, ifnecessary, cleaned. The instrument can then be sterilized. In onesterilization technique, the instrument is placed in a closed and sealedcontainer, such as a plastic or TYVEK bag. The container and itscontents can then be placed in a field of radiation that can penetratethe container, such as gamma radiation, x-rays, or high-energyelectrons. The radiation can kill bacteria on the instrument and in thecontainer. The sterilized instrument can then be stored in the sterilecontainer. The sealed container can keep the instrument sterile until itis opened in the medical facility.

In many embodiments, it is preferred that the device is sterilized. Thiscan be done by any number of ways known to those skilled in the artincluding beta or gamma radiation, ethylene oxide, steam, and a liquidbath (e.g., cold soak). In certain embodiments, the materials selectedfor use in forming components such as the elongate body may not be ableto withstand certain forms of sterilization, such as gamma radiation. Insuch a case, suitable alternative forms of sterilization can be used,such as ethylene oxide.

One skilled in the art will appreciate further features and advantagesof the invention based on the above-described embodiments. Accordingly,the invention is not to be limited by what has been particularly shownand described, except as indicated by the appended claims. Allpublications and references cited herein are expressly incorporatedherein by reference in their entirety.

1. A method for forming an ablation treatment volume in tissue having adesired shape, comprising: delivering therapeutic energy to tissue toform an ablation treatment volume in the tissue; and simultaneouslydelivering a first fluid and a second fluid to the tissue, the first andsecond fluids convecting the therapeutic energy in a desired directionsuch that the ablation treatment volume has a desired shape.
 2. Themethod of claim 1, wherein the first and second fluids are delivered atdifferent temperatures.
 3. The method of claim 1, wherein the first andsecond fluids are delivered through one or more elongate bodies insertedinto the tissue.
 4. The method of claim 1, further comprising adjustingany of a fluid flow rate and a fluid temperature for any of the firstfluid and the second fluid to further shape the ablation treatmentvolume.
 5. The method of claim 1, further comprising adjusting a levelof therapeutic energy delivered to the tissue to further shape theablation treatment volume.
 6. The method of claim 1, wherein deliveringtherapeutic energy to tissue comprises activating an ablation elementconfigured to transmit electrical energy into the tissue.
 7. The methodof claim 1, wherein the first fluid is delivered from first and secondopposed longitudinal portions of an inner lumen of an elongate body, andthe second fluid is delivered from third and fourth opposed longitudinalportions of the inner lumen, the third and fourth portions beingradially offset from the first and second portions.
 8. The method ofclaim 1, wherein delivering the first fluid comprises ejecting the firstfluid from at least one outlet port formed in a proximal portion of asidewall of an elongate member, and delivering the second fluidcomprises ejecting the second fluid from at least one outlet port formedin a distal portion of a sidewall of an elongate member adjacent to theproximal portion.
 9. The method of claim 1, further comprising repeatingthe steps of delivering therapeutic energy and simultaneously deliveringa first fluid and a second fluid in a plurality of locations to form atreatment volume having an elongate planar shape.
 10. A method forshaping therapeutic energy delivered to tissue comprising: positioning afirst elongate body in a patient's body at a first location, the firstelongate body having an inner lumen extending therethrough, at least oneoutlet port formed therein, at least one ablation element disposed alonga length thereof, and at least one heater element disposed within theinner lumen; positioning a second elongate body in a patient's body at asecond location, the second elongate body having an inner lumenextending therethrough and at least one outlet port formed therein; andsimultaneously delivering a first fluid from the first elongate body anda second fluid from the second elongate body such that the first andsecond fluids interact to shape an ablation treatment volume.
 11. Themethod of claim 10, wherein the first fluid and the second fluid are atdifferent temperatures.
 12. The method of claim 10, further comprisingdelivering therapeutic energy from the ablation element disposed alongthe first elongate body.
 13. The method of claim 10, wherein positioningthe first elongate body at a first location and positioning the secondelongate body at a second location comprises positioning in a patient'sbody an elongate member having the first and second elongate bodiesdisposed thereon.
 14. The method of claim 10, wherein the secondelongate body is positioned at a location adjacent to a structure to beprotected from therapeutic energy.
 15. An ablation device, comprising:an elongate body having proximal and distal ends, an inner lumenextending through the elongate body, at least two outlet ports formed inthe elongate body and configured to deliver fluid to tissue surroundingthe elongate body, and at least one ablation element disposed along adistal portion of the elongate body, the ablation element beingconfigured to heat tissue surrounding the ablation element when theelongate body is inserted into tissue; wherein the at least two outletports are configured to deliver fluid at different temperatures.
 16. Thedevice of claim 15, further comprising at least one heater elementassociated with one or more of the two outlet ports, the at least oneheater element being disposed within the inner lumen and configured toheat fluid flowing to the one or more associated outlet ports.
 17. Thedevice of claim 15, further comprising at least one dividing memberdisposed within the inner lumen and configured to divide the inner lumeninto two or more portions not in fluid communication with each other;wherein each portion is in communication with one or more of the atleast two outlet ports.
 18. The device of claim 17, wherein the at leastone dividing member divides the inner lumen into four portions extendinglongitudinally along the inner lumen so as to divide the inner lumeninto quadrants having opposed pairs; wherein a heater element isdisposed within each portion of the first opposing pair of quadrantsthat is configured to heat fluid flowing therethrough to a firsttemperature; and wherein a heater element is disposed within eachportion of the second opposing pair of quadrants that is configured toheat fluid flowing therethrough to a second temperature that is lessthan the first temperature.
 19. The device of claim 17, wherein the atleast one dividing member divides the inner lumen into a proximalportion and a distal portion wherein each portion is associated with adifferent ablation element.
 20. The device of claim 19, wherein the atleast one dividing member comprises at least two dividing members thatfurther divide the inner lumen to create a third portion that isproximal or distal to the distal portion.
 21. The device of claim 17,further comprising two or more temperature sensors, wherein eachtemperature sensor is disposed in a different portion of the innerlumen.
 22. An ablation device comprising: an elongate member having adistal end configured for introduction into a patient's body; at leasttwo elongate bodies disposed on the distal end of the elongate member;wherein each of the elongate bodies includes proximal and distal ends,an inner lumen extending therethrough, and at least one outlet portformed in the elongate body and configured to deliver fluid to tissuesurrounding the elongate body; wherein at least one of the at least twoelongate bodies includes at least one ablation element disposed along adistal portion of the elongate body, the ablation element beingconfigured to heat tissue surrounding the ablation element; and whereinat least one of the at least two elongate bodies includes a heaterelement disposed within the inner lumen of the elongate body, the heaterelement being configured to heat fluid flowing through the inner lumen.23. The ablation device of claim 22, wherein the at least two elongatebodies comprise first, second, and third elongate bodies arranged aroundthe distal end of the elongate member a distance away from alongitudinal axis of the elongate member.